Site Care Partner II

Role Overview

• Building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies
• Site-level recruitment and accountable for safeguarding the quality and patient safety at the investigator site
• Subject Matter Expert aimed to optimize country and site selection activities by proactively collaborating with key stakeholders and providing local intelligence to country outreach surveys, investigator strategies and Pfizer pipeline opportunities
• Ensuring that sites receive necessary support and engagement, issues are resolved, and Pfizer’s reputation is upheld throughout study lifecycle
• Coordination with other roles and functions that will interface with study sites (e.g. CRA/Site Monitor, Investigator Contracts Lead, Site Activation Partner, Clinician, etc.) thereby, optimizing communications and enhancing overall visibility into and confidence of quality of site level activities
• Site quality by utilizing and interpreting data from analytic tools, in conjunction with country intelligence and IRMS to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks
• Conducting study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV, including management of issues that may compromise time to site activation
• Ensuring all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation
• Supporting country specific ICD review and deployment when applicable
• Ensuring follow up activities ’completion post PTA and SIV to ensure site readiness for FSFV
• Partnering with CRA/site monitor to ensure site monitoring readiness in anticipation of first subject first visit
• Relationship building and operational quality of the site
• Providing study support on escalated site issues related to study delivery by coordinating communications and resolution efforts
• Ensuring the strategy/approach for IP and ancillary supplies for sites and country requirement throughout the lifecycle of the study
• Effective site recruitment planning and delivery, consistent with global and/or country plan and local targets
• Establishing and maintaining relationships with Site Organizations and Strategic Partners
• Accountable for study conduct and close-out
• Reviewing Site Reports and related issues
• Demonstrate leadership within the local clinical development environment with a goal to enhance Pfizer reputation in scientific leadership
• Act as a Subject Matter Expert on Pfizer systems and processes

Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 7 years’ experience)
• Proficiency in local language preferred
• English is required
• Demonstrated experience in site management with prior experience as a CRA/Site monitor
• Demonstrated experience in start up activities through to site activation
• Demonstrated experience in conduct and close out activities
• Demonstrated knowledge of quality and regulatory requirements in the United States
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage required travel (in the United States)
• Demonstrated networking and relationship building skills
• Demonstrated ability to manage cross functional relationships
• Ability to communicate effectively and appropriately with internal & external stakeholders
• Ability to adapt to changing technologies and processes

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Additional Pfizer Retirement Savings Contribution
• Paid vacation
• Holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental and vision coverage